LEVERKUSEN (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) announced encouraging outcomes from the Phase 3 QUASAR trial, which evaluated the efficacy of EYLEA HD (aflibercept) Injection 8 mg for treating macular edema due to retinal vein occlusion (RVO). This includes patients with central, branch, and hemiretinal vein occlusions. The data from this trial will support a supplemental Biologics License Application submission to the U.S. Food and Drug Administration in the first quarter of 2025.
The QUASAR trial met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA (aflibercept) Injection 2 mg dosed every 4 weeks.
The EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions.
Furthermore, in patients treated with EYLEA HD through 36 weeks, 88% of patients were able to sustain an 8-week dosing regimen following 3 initial monthly doses, and 93% of patients maintained an 8-week dosing regimen after completing 5 initial monthly doses.
The company noted that the safety profile of EYLEA HD was similar to EYLEA in QUASAR and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment-emergent adverse events (TEAEs) occurring in greater than or equal to 5% of all EYLEA HD patients included increased ocular pressure (5%); there was one case each of endophthalmitis and retinal vasculitis. The rate of intraocular inflammation was 0.5% for EYLEA HD and 1.3% for EYLEA.
EYLEA HD, which is known as Eylea 8 mg in the European Union and Japan, is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD.
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